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The Position

Primary Purpose of Job (Job Summary)
Ensures that collection reporting and handling of safety information associated with Roche products is performed according to global Roche and local regulatory requirements.

Demonstrates independence and high competence in the conduct of all safety science responsibilities.
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Maintains oversight of the management of safety information safety risk management and all other pharmacovigilance (PV) activities ensuring PV medical compliance (Roche policies and procedures global and local regulatory requirements) and inspection readiness
(PV) PV
Design and execute safety strategy efficiently to optimize all safety activities in Medical. Provide supports to safety evaluation activities contribute consultant to medical projects and ensure timely safety communication. Contribute to safety science deliverables required to maintain license labeling document and NDA et al.

Maintain relationship with internal (local and global) and external parties such as authorities for update and alignment of regulation and collaboration of safety matters.

Own PV business processes and ensure knowing well about Roche product knowledge.
PV . Independently manage safety responsibilities mentor junior members in the team and take the lead on more complex deliverables and projects requiring more coordination and insights such as lead the safety process development activities and the education platform in PV function

Principle Roles & Responsibilities / Accountabilities / (Major functions of the position)

Maintains oversight of the management of safety information safety risk management and all other pharmacovigilance (PV) activities ensuring PV medical compliance (Roche policies and procedures global and local regulatory requirements) and inspection readiness. Designing & execution of safety strategy and ensure high quality deliveries.
(PV)
a) Independently perform proactive safety surveillance and risk management including product safety signal detection & evaluation risk assessment and safety risk minimization.

Ensure knowing well about product safety risk management knowledge.

Contribute to development of local RMP and ensures oversight of its implementation in collaboration with relevant staff in accordance with Roche policies and procedures global and local regulatory requirements.
RMP RMP
b) Act as a safety expert in the Disease Area Strategy Teams Design and execute safety strategy efficiently to optimize all safety activities in Medical. Ensuring a unified communication on safety matters. Perform frequent proactive Holistic Safety Review for products across the span of relevant available safety data information. Reviews are incremental cumulative and aggregate to include the body of safety information available (e.g. clinical epidemiology spontaneous literature & regulatory cases other scientific data)

c) Acts independently to manage safety responsibilities on study teams and in activities supporting safety science. Provide safety input to Medical studies by reviewing safety section of study document. Ensures appropriate safety reporting processes are in place at affiliate level and if applicable described in relevant local documents for global and local interventional clinical trials Non-interventional Studies (NISs) Post Authorization Studies(PASS/PAES) Pre-Approval and Post Trial Access Programs and Compassionate Use in accordance with Roche policies and procedures global and local regulatory requirements.
(NIS) (PASS/PAES)
d) Provides safety related information to global teams for the preparation of Aggregate Reports where applicable. Ensures preparation of Aggregate Reports for local products where applicable in collaboration with local Drug Regulatory Affairs (e.g. license renewal).

e) Provides the clinical safety teams and/or QPPV office and external key stakeholders (as applicable) with all relevant safety information.
/ QPPV
f) Provide safety input to local labels generation and maintenance. Ensures awareness of and contributes as applicable to local safety label updates. Contributes to the implementation of PV commitments when applicable.

g) Maintains oversight of the Direct Healthcare Professional Communication (DHPC) Dear Investigator Letter (DIL) & To Whom It May Concern Letter (TWIMCL) processes.
(DHPC) (DIL) (TWIMCL)
h) Work with the relevant SRPL functions for responses to safety queries and the solution of high impact cases from China regulatory agency media patients medical community and investigators. Ensures that management of safety queries other significant safety issues and if applicable local/global crises is performed according to global Roche and local regulatory authority requirements.
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i) Proactively supports the Local Safety Responsible in all safety evaluation activities.
Represent Drug Safety Science with business process owners on processes executed by Drug Safety Science. Generate and maintain local SOPs taking into account the global SOPs and local regulation.

SOP SOP
k) Engagement in audit & inspection readiness and support. Act as SME for affiliate PV-related CAPAs. Provision of data to project managers for metrics and activity tracking.

l) Provides input for the relevant service provider Functional Oversight Responsible to ensure that PV requirements are met.

m) Support the team leader in all Safety Science activities.

Enhance internal and external collaboration:

a) Independently manage safety responsibilities mentor junior members in the team and take the lead on more complex deliverables and projects requiring more coordination and insights such as lead the safety process development activities and the education platform in PV function
b) Serve as interface and build up internal cross-functional partnership with focus on the commercial regional and global counterparts.

c) Build active connection and support team member in discussion with authority for update and alignment of regulation relevant RA commitment.

d) Keeps up to date with local regulations and acts as the nominated person for PV if required by local regulations.
PV
Compliance adherence:

Implement ICH GCP GVP local regulations and Roche SOP to ensure all medical initiatives in line with relevant SOPs and codes
ICH GCPGVP SOP SOP

Qualification and Experience
Education/Qualifications/
Master Degree in Clinical Medicine or above

Clinical experience will be preferred

Other life sciences background with significant experience in Drug Safety (especially Safety Science) can be acceptable if approved by LSR on a case by case basis provided medical oversight is ensured.

Appreciation of GxP and regulatory policies.
GxP
MNC pharmaceutical company experience in medical/PV related role will be preferred
MNC
Leadership Competencies
Ability to drive the delivery of commitment in a matrix team

Job Required Competencies
Good Knowledge:

Drug safety knowledge and relevant TA/disease area

Drug safety relevant regulations (ICHEMAFDAif relevantand local regulation)
ICHEMAFDA
Medical knowledge of Roche products and relevant TA/disease area

Medical terminology in Englishverbal and written
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Good communication skills and presentation skills

Good understanding of GVP GCP and other clinical study process within the pharmaceutical sector
GVPGCP
Good organization and planning skills

Strategic thinking

Influencing skills. Ability to motive the team members and other functions working towards shared goals.

Ability to work independently and cooperate and interact well in a multifunctional team setting

Relevant working experience: at least 3-5 years of clinical and/or DS experience
3-5 /
Language: Fluency in English and Chinese written and verbal.

Computer skill: Computer literacy usage of MS Office software web-based systems and databases.
MS Office web
Roche Core Competencies

Proven ability to demonstrate Roche Values and Leadership Commitments

The statements made here are intended to describe the general nature and level of work being performed by people assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities duties and skills required of people assigned to this job.

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.